FDA Approves Teal Wand as First At-Home Cervical Cancer Screening
Teal Health, the company manufacturing and distributing the test, says thousands of women are already on a waiting list for the assay
FDA-dtet
Diagnostics Pipeline: FDA Approves Visby Medical’s Over-The-Counter Women’s Sexual Health Test
It’s the first PCR-based sexually transmitted infection test platform for at-home use
Diagnostics Pipeline: 2024 Trends in FDA Approvals
In vitro diagnostic products approved by the U.S. Food and Drug Administration in 2024 show a continued move toward rapid and point-of-care tests
FDA Watch: Agency Issues New Guidance on Biotin Interference Testing
From - Diagnostic Testing & Emerging Technologies
On June 13, the FDA issued a draft guidance explaining how makers of in vitro diagnostic devices (IVDs) should perform…
FDA Greenlights Assays Using New Test Model for Lyme Disease Diagnosis
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Compliance Alert: FDA Warning Letter to Inova Genomics Laboratory
FDA Issues Warning for ‘Over Reliance’ on Rupture of Membrane Tests
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FDA Considering Self-Collection Sample Regulation
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FDA Medical Device User Fees Rise as Part of Reauthorization
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Kellison Award goes to FDA’s Dr. Alberto Gutierrez
From - Laboratory Industry Report
Dr. Alberto Gutierrez is the 2017 recipient of the Kellison Lab Industry Distinguished Service Award. Dr. Guitierrez retired in August after…
FDA Reports Progress in Advancing Regulatory Science for Diagnostics
From - Diagnostic Testing & Emerging Technologies
The U.S. Food and Drug Administration (FDA) recently unveiled its FY 2015-2016: Regulatory Science Progress Report. The report, the second of its kind under the…
